Tuberculosis DiagnosisTBNCT06984887
Evaluation of New TB Diagnostic Tests (NATs) in Pakistan
A study testing Paired tongue-swab and sputum-based molecular testing for tuberculosis in people with Tuberculosis Diagnosis, run by Mercy Corps Pakistan at 2 sites in Pakistan.
Trial summary
This study evaluates two portable molecular tests for tuberculosis (TB), Pluslife MTBC and Ustar PortNAT, during community-based active case-finding activities in Pakistan. It compares testing of tongue swabs and sputum swabs with the routinely used sputum Xpert MTB/RIF Ultra test. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Diagnosis
- What is being tested?
- Paired tongue-swab and sputum-based molecular testing for tuberculosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,100 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Feb 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 12 years or older.
- Attendance at a participating tuberculosis active case-finding activity with chest X-ray screening and an available computer-aided detection (CAD) score.
- Any sex.
- Informed consent to participate and willingness to provide at least one study specimen (tongue swab and/or sputum). Participants aged 12-17 years provide assent with parent or guardian consent in accordance with the approved protocol.
- Inability to produce sputum is not an exclusion criterion. Sputum induction may be offered under the study procedures. Participants unable to provide sputum remain eligible for tongue-swab collection; unavailable sputum-based test and culture results are recorded separately.
Who cannot join
- Refusal of informed consent or required assent/guardian consent.
- Inability to comply with study procedures or follow-up.
- Pregnancy.
- Known pulmonary tuberculosis.
- Known extrapulmonary tuberculosis.
- No chest X-ray screening or unavailable CAD score.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
National Reference Laboratory
Islamabad, Federal Capital, 44000
Provincial Reference Laboratory, Dow University of Health Sciences
Karachi, Sindh
About this study
Official title: Evaluation of Portable Nucleic Acid Amplification Tests for Tuberculosis Active Case Finding in Pakistan
This study evaluates two portable molecular tests for tuberculosis (TB), Pluslife MTBC and Ustar PortNAT, during community-based active case-finding activities in Pakistan. It compares testing of tongue swabs and sputum swabs with the routinely used sputum Xpert MTB/RIF Ultra test. Mycobacterial culture is the microbiological reference standard used to assess diagnostic accuracy.
The study examines how often each test detects TB when culture is positive and how often it gives a negative result when culture is negative. Results will be assessed separately for each test and specimen type. The study also compares specimen collection, test usability, costs and time to results, and explores participants' and health-care workers' experiences and preferences regarding tongue-swab and sputum collection.
Read the detailed description
Study design and diagnostic comparison
This is a prospective, paired, cross-sectional diagnostic accuracy study embedded within community-based tuberculosis active case finding in Pakistan. Pluslife MTBC and Ustar PortNAT are the index tests, evaluated separately using tongue swabs and sputum swabs. Sputum Xpert MTB/RIF Ultra is the comparator, and mycobacterial culture is the microbiological reference standard. Comparisons are made within the same participants using matched specimens.
The primary diagnostic objectives are to estimate sensitivity against culture and the paired absolute difference in sensitivity between each index-test/specimen strategy and Xpert Ultra. The non-inferiority question uses a margin of 5 percentage points for sensitivity. Non-inferiority means that sensitivity is not lower than the comparator by more than this margin; it does not mean equality. Specificity against culture is a key secondary outcome. Positive and negative percentage agreement with Xpert are distinct from culture-referenced sensitivity and specificity.
Population and sampling
Participants aged 12 years or older are selected from routine active case-finding attendees with available chest X-ray computer-aided detection (CAD) scores. The planned sampling includes attendees with CAD scores of 60 or higher and every tenth attendee with scores below 60. Analyses intended to represent the eligible ACF population will account for the implemented sampling probabilities. Both CAD groups contribute to sensitivity and specificity estimates. Inability to produce sputum does not itself prevent enrolment under the revised eligibility criteria. Unavailable specimens, unperformed or invalid tests, and unresolved cultures will be recorded separately rather than classified as negative results.
Operational feasibility and costs
Quantitative assessments include specimen collection success, test validity and repeat testing, costs, and turnaround time. Collection, laboratory processing, assay runtime and result reporting will be distinguished according to the available measurements. Cost-effectiveness will be assessed under the study's health-economic analysis plan.
Acceptability and usability
Semi-structured interviews and participant assessments will explore the experiences, preferences and challenges of tongue-swab and sputum collection among sample providers and health-care workers. These assessments address usability, convenience, logistical barriers and implementation feasibility.
Analysis and transparency
Accuracy estimates and paired comparisons will be reported separately for each platform and specimen type with confidence intervals. The approved protocol and statistical analysis plan define culture classification, paired analysis populations, sampling adjustment, handling of missing or indeterminate results and non-inferiority inference. Revisions to eligibility or outcome definitions will be documented as amendments with their timing relative to enrolment and review of interim results.
Amendment timing
The revised eligibility and outcome definitions were approved and effective on 15 February 2026, before the actual study start on 20 February 2026. These revisions are being entered in the registry update of October 2026. The approval date for these definitions does not establish the date of finalisation of subsequent statistical analysis plan revisions.
- Conditions
- Tuberculosis Diagnosis
- Being tested
- Paired tongue-swab and sputum-based molecular testing for tuberculosis
- Keywords
- New TB diagnostics, New NATs for TB, Cost efficient TB diagnostic tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired tongue-swab and sputum-based molecular testing for tuberculosisDiagnostic test
Collection of tongue swabs and sputum specimens during routine community-based active case finding. Tongue-swab and sputum-swab specimens are evaluated separately using Pluslife MTBC and Ustar PortNAT. Sputum Xpert MTB/RIF Ultra is the comparator and sputum mycobacterial culture is the microbiological reference standard. Diagnostic tests are performed on matched specimens from the same participant under the study laboratory procedures. Participants who cannot provide sputum remain eligible for tongue-swab collection under the revised criteria; unavailable sputum-based tests or cultures are recorded as unavailable, not negative. Diagnostic accuracy, paired sensitivity differences, collection success, validity, turnaround time, costs and acceptability are evaluated as specified in the protocol and analysis plans.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Trial | Experimental | Not described Receives: Diagnostic Test: Paired tongue-swab and sputum-based molecular testing for tuberculosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Pluslife MTBC and Ustar PortNAT against mycobacterial culture
Percentage of participants with culture-confirmed Mycobacterium tuberculosis complex who have a positive index-test result, calculated separately for Pluslife tongue swab, Pluslife sputum swab, Ustar tongue swab and Ustar sputum swab. Each estimate uses participants with an evaluable culture reference and valid result for the relevant strategy. Numerators, denominators and confidence intervals will be reported; sampling adjustment will follow the statistical analysis plan. Unavailable specimens, invalid tests and unresolved cultures are not classified as negative. These definitions clarify the originally registered test-result counts under the approved amendment; original definitions and amendment timing remain documented.
Measured: From enrolment to the end of results confirmation at 8 weeks
Paired difference in sensitivity between each index strategy and Xpert MTB/RIF Ultra
Absolute difference in sensitivity, in percentage points, calculated as sensitivity of the index strategy minus sensitivity of sputum Xpert MTB/RIF Ultra among the same culture-positive participants with valid results for both tests. Comparisons are separate for Pluslife tongue swab, Pluslife sputum swab, Ustar tongue swab and Ustar sputum swab. Paired confidence intervals and sampling adjustment will follow the statistical analysis plan. The non-inferiority margin is -5 percentage points; non-inferiority requires the relevant lower confidence bound to exceed -5 percentage points, accounting for the specified comparison family and prior interim analyses. Non-significant equality testing does not establish non-inferiority.
Measured: From enrolment through diagnostic result confirmation, up to 8 weeks per participant.
Secondary outcomes (6)
Specificity of Pluslife MTBC and Ustar PortNAT against mycobacterial culture
Percentage of culture-negative participants with a negative index-test result, reported separately for Pluslife tongue swab, Pluslife sputum swab, Ustar tongue swab and Ustar sputum swab. Culture-negative status is determined using the approved composite culture definition. Participants from both CAD strata contribute. Report numerator, denominator and confidence interval, with sampling adjustment under the statistical analysis plan. Unresolved cultures and invalid or unavailable index results are not coded negative. Paired specificity differences versus Xpert Ultra will be reported on the corresponding common evaluable population.
Measured: From enrolment through diagnostic result confirmation, up to 8 weeks per participant.
Successful tongue-swab and sputum collection
Percentage of participants offered each specimen type who successfully provide a tongue-swab or sputum specimen. Report complete, partial, unsuccessful and refused collection separately, together with the proportion requiring sputum induction. Denominators include participants unable to provide a specimen rather than only those successfully tested.
Measured: During specimen collection at the enrolment visit.
Invalid or error results and valid-result availability
Percentage of attempted tests returning an invalid, error or uninterpretable result, separately for each platform and specimen type. Report first-attempt and final results after permitted repeats where attempt history is available. Also report the percentage of enrolled participants with an available valid result for each strategy, distinguishing collection failure, unperformed testing and assay failure.
Measured: From specimen collection through completion of diagnostic testing, up to 8 weeks per participant.
Laboratory turnaround time and assay runtime
Time from specimen receipt at the laboratory to result reporting, measured in hours, separately for each diagnostic platform and specimen type. Summarise the distribution with median and interquartile range. Assay runtime in minutes will be reported separately and will not be interpreted as patient-level time to diagnosis. Missing timestamps and incomplete result reporting will be described.
Measured: From laboratory specimen receipt to diagnostic result reporting, up to 8 weeks per participant.
Cost per diagnostic test performed
Mean cost per test performed for each diagnostic platform and specimen strategy, calculated from the resource-use and cost data collected under the health-economic analysis plan. Report the costing perspective, included resource categories, price year and reporting currency. Distinguish cost per attempted test from cost per valid result where reported; broader cost-effectiveness analyses follow the separate economic plan.
Measured: During study implementation through study completion, approximately 13 months.
Acceptability and usability of tongue-swab versus sputum collection
Participant-reported collection difficulty using the study's 1-10 scale (1 extremely easy, 10 extremely difficult), reported separately for tongue swabs and sputum, and specimen preferences where collected. Semi-structured interviews with sample providers and health-care workers will be analysed thematically to describe convenience, usability, logistical challenges and barriers to collection. Qualitative themes will be distinguished from numerical questionnaire outcomes.
Measured: Participant ratings at specimen collection; interviews during study implementation through completion, approximately 13 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start20 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, paired, cross-sectional diagnostic accuracy evaluation within routine active case finding for tuberculosis in Pakistan. Participants contribute matched tongue-swab and sputum specimens for evaluation of Pluslife MTBC and Ustar PortNAT, with each platform and specimen strategy analysed separately. Sputum Xpert MTB/RIF Ultra is the comparator and mycobacterial culture is the microbiological reference standard. Sensitivity and specificity are estimated against culture. Sensitivity differences between each index strategy and Xpert are assessed within the same culture-positive participants. The non-inferiority hypothesis uses a 5 percentage-point sensitivity margin and confidence intervals for the paired difference; non-inferiority does not imply equality. Missing specimens, invalid tests and unresolved culture results are distinguished from negative results under the statistical analysis plan.
- Masking
- None (open label)
- Enrolment
- 6,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Corps Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Global Public Health Pakistan, Institute of Tropical Medicine(KIT), Amsterdam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984887
- Sponsor's protocol ID
- INV-045723-Diagnostic
- Other IDs
- INV-045723, STBP/TBREACH/GSA/2025-01
- Acronym
- TB
- Status last verified
- Oct 2026
- First submitted
- 14 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Portable Nucleic Acid Amplification Tests for Tuberculosis Active Case Finding in Pakistan
- ClinicalTrials.gov ID
- NCT06984887
- Acronym / sponsor ID
- TB / INV-045723-Diagnostic
- Conditions
- Tuberculosis Diagnosis
- Keywords
- New TB diagnostics, New NATs for TB, Cost efficient TB diagnostic tools
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6,100 participants (estimated)
- Lead sponsor
- Mercy Corps PakistanUniversity, hospital or other
- Collaborators
- Centre for Global Public Health Pakistan, Institute of Tropical Medicine(KIT), Amsterdam
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates two portable molecular tests for tuberculosis (TB), Pluslife MTBC and Ustar PortNAT, during community-based active case-finding activities in Pakistan. It compares testing of tongue swabs and sputum swabs with the routinely used sputum Xpert MTB/RIF Ultra test. Mycobacterial culture is the microbiological reference standard used to assess diagnostic accuracy.
The study examines how often each test detects TB when culture is positive and how often it gives a negative result when culture is negative. Results will be assessed separately for each test and specimen type. The study also compares specimen collection, test usability, costs and time to results, and explores participants' and health-care workers' experiences and preferences regarding tongue-swab and sputum collection.
Detailed description
Study design and diagnostic comparison
This is a prospective, paired, cross-sectional diagnostic accuracy study embedded within community-based tuberculosis active case finding in Pakistan. Pluslife MTBC and Ustar PortNAT are the index tests, evaluated separately using tongue swabs and sputum swabs. Sputum Xpert MTB/RIF Ultra is the comparator, and mycobacterial culture is the microbiological reference standard. Comparisons are made within the same participants using matched specimens.
The primary diagnostic objectives are to estimate sensitivity against culture and the paired absolute difference in sensitivity between each index-test/specimen strategy and Xpert Ultra. The non-inferiority question uses a margin of 5 percentage points for sensitivity. Non-inferiority means that sensitivity is not lower than the comparator by more than this margin; it does not mean equality. Specificity against culture is a key secondary outcome. Positive and negative percentage agreement with Xpert are distinct from culture-referenced sensitivity and specificity.
Population and sampling
Participants aged 12 years or older are selected from routine active case-finding attendees with available chest X-ray computer-aided detection (CAD) scores. The planned sampling includes attendees with CAD scores of 60 or higher and every tenth attendee with scores below 60. Analyses intended to represent the eligible ACF population will account for the implemented sampling probabilities. Both CAD groups contribute to sensitivity and specificity estimates. Inability to produce sputum does not itself prevent enrolment under the revised eligibility criteria. Unavailable specimens, unperformed or invalid tests, and unresolved cultures will be recorded separately rather than classified as negative results.
Operational feasibility and costs
Quantitative assessments include specimen collection success, test validity and repeat testing, costs, and turnaround time. Collection, laboratory processing, assay runtime and result reporting will be distinguished according to the available measurements. Cost-effectiveness will be assessed under the study's health-economic analysis plan.
Acceptability and usability
Semi-structured interviews and participant assessments will explore the experiences, preferences and challenges of tongue-swab and sputum collection among sample providers and health-care workers. These assessments address usability, convenience, logistical barriers and implementation feasibility.
Analysis and transparency
Accuracy estimates and paired comparisons will be reported separately for each platform and specimen type with confidence intervals. The approved protocol and statistical analysis plan define culture classification, paired analysis populations, sampling adjustment, handling of missing or indeterminate results and non-inferiority inference. Revisions to eligibility or outcome definitions will be documented as amendments with their timing relative to enrolment and review of interim results.
Amendment timing
The revised eligibility and outcome definitions were approved and effective on 15 February 2026, before the actual study start on 20 February 2026. These revisions are being entered in the registry update of October 2026. The approval date for these definitions does not establish the date of finalisation of subsequent statistical analysis plan revisions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, paired, cross-sectional diagnostic accuracy evaluation within routine active case finding for tuberculosis in Pakistan. Participants contribute matched tongue-swab and sputum specimens for evaluation of Pluslife MTBC and Ustar PortNAT, with each platform and specimen strategy analysed separately. Sputum Xpert MTB/RIF Ultra is the comparator and mycobacterial culture is the microbiological reference standard. Sensitivity and specificity are estimated against culture. Sensitivity differences between each index strategy and Xpert are assessed within the same culture-positive participants. The non-inferiority hypothesis uses a 5 percentage-point sensitivity margin and confidence intervals for the paired difference; non-inferiority does not imply equality. Missing specimens, invalid tests and unresolved culture results are distinguished from negative results under the statistical analysis plan.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Trial | Experimental | Diagnostic Test: Paired tongue-swab and sputum-based molecular testing for tuberculosis |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 12 years or older.
- Attendance at a participating tuberculosis active case-finding activity with chest X-ray screening and an available computer-aided detection (CAD) score.
- Any sex.
- Informed consent to participate and willingness to provide at least one study specimen (tongue swab and/or sputum). Participants aged 12-17 years provide assent with parent or guardian consent in accordance with the approved protocol.
- Inability to produce sputum is not an exclusion criterion. Sputum induction may be offered under the study procedures. Participants unable to provide sputum remain eligible for tongue-swab collection; unavailable sputum-based test and culture results are recorded separately.
Key exclusion criteria (6 listed)
- Refusal of informed consent or required assent/guardian consent.
- Inability to comply with study procedures or follow-up.
- Pregnancy.
- Known pulmonary tuberculosis.
- Known extrapulmonary tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paired tongue-swab and sputum-based molecular testing for tuberculosisCollection of tongue swabs and sputum specimens during routine community-based active case finding. Tongue-swab and sputum-swab specimens are evaluated separately using Pluslife MTBC and Ustar PortNAT. Sputum Xpert MTB/RIF Ultra is the comparator and sputum mycobacterial culture is the microbiological reference standard. Diagnostic tests are performed on matched specimens from the same participant under the study laboratory procedures. Participants who cannot provide sputum remain eligible for tongue-swab collection under the revised criteria; unavailable sputum-based tests or cultures are recorded as unavailable, not negative. Diagnostic accuracy, paired sensitivity differences, collection success, validity, turnaround time, costs and acceptability are evaluated as specified in the protocol and analysis plans. | Diagnostic test | Diagnostic Trial |
Primary outcome
Sensitivity of Pluslife MTBC and Ustar PortNAT against mycobacterial culture
Time frame: From enrolment to the end of results confirmation at 8 weeks
Percentage of participants with culture-confirmed Mycobacterium tuberculosis complex who have a positive index-test result, calculated separately for Pluslife tongue swab, Pluslife sputum swab, Ustar tongue swab and Ustar sputum swab. Each estimate uses participants with an evaluable culture reference and valid result for the relevant strategy. Numerators, denominators and confidence intervals will be reported; sampling adjustment will follow the statistical analysis plan. Unavailable specimens, invalid tests and unresolved cultures are not classified as negative. These definitions clarify the originally registered test-result counts under the approved amendment; original definitions and amendment timing remain documented.
Paired difference in sensitivity between each index strategy and Xpert MTB/RIF Ultra
Time frame: From enrolment through diagnostic result confirmation, up to 8 weeks per participant.
Absolute difference in sensitivity, in percentage points, calculated as sensitivity of the index strategy minus sensitivity of sputum Xpert MTB/RIF Ultra among the same culture-positive participants with valid results for both tests. Comparisons are separate for Pluslife tongue swab, Pluslife sputum swab, Ustar tongue swab and Ustar sputum swab. Paired confidence intervals and sampling adjustment will follow the statistical analysis plan. The non-inferiority margin is -5 percentage points; non-inferiority requires the relevant lower confidence bound to exceed -5 percentage points, accounting for the specified comparison family and prior interim analyses. Non-significant equality testing does not establish non-inferiority.
6 secondary outcomes
Specificity of Pluslife MTBC and Ustar PortNAT against mycobacterial culture
Time frame: From enrolment through diagnostic result confirmation, up to 8 weeks per participant.
Successful tongue-swab and sputum collection
Time frame: During specimen collection at the enrolment visit.
Invalid or error results and valid-result availability
Time frame: From specimen collection through completion of diagnostic testing, up to 8 weeks per participant.
Laboratory turnaround time and assay runtime
Time frame: From laboratory specimen receipt to diagnostic result reporting, up to 8 weeks per participant.
Cost per diagnostic test performed
Time frame: During study implementation through study completion, approximately 13 months.
Acceptability and usability of tongue-swab versus sputum collection
Time frame: Participant ratings at specimen collection; interviews during study implementation through completion, approximately 13 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tuberculosis Diagnosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Tuberculosis (TB)
RecruitingObservational study
Biomarker Analysis for Diagnosing and Treatment Monitoring in Extrapulmonary Tuberculosis Patients in Nairobi, Kenya
Tuberculosis, Extrapulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paired tongue-swab and sputum-based molecular testing for tuberculosis in people with Tuberculosis Diagnosis, run by Mercy Corps Pakistan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Pluslife MTBC and Ustar PortNAT against mycobacterial culture (time frame: From enrolment to the end of results confirmation at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.